Abstract
The norovirus – commonly known as the winter vomiting bug – is highly infectious and causes vomiting and diarrhoea. It closes hospital wards, and spreads rapidly through schools and care homes. Although most people recover in a few days, it can have a serious impact on those who have underlying health conditions. A vaccine has been developed that is ready for human trials. Initial multi-centre trials require healthy young adult volunteers.
One centre involved in the research is situated close to a university campus and is intending to publicize the need for volunteers amongst the student body, although students are not the sole target group. Adverts in the local press and the centre’s own database will be used to target potential participants.
Participants will be required to stay at the test centre for five days. The incubation period of the virus can be up to 48 hours, and so participants who do not develop symptoms can be discharged safely after five days. If they succumb to the virus they will be given any necessary medical treatment and required to stay at the centre until medical staff authorize their discharge, which could require a stay of more than five days. They will also be given advice on how to minimize transmission of the virus, as people can remain infectious for up to three weeks. Participants will be given an ‘inconvenience’ payment of £50 per day that they stay at the test centre, so the minimum payment will be £250. Given the unpleasant symptoms of norovirus it is thought that few would take such a risk without payment and that people should be rewarded for doing so. In order to prevent person-to-person transmission, participants will be kept isolated from each other for the duration of their stay. In order to prevent contamination of personal belongings the participants will not be permitted to bring anything other than a phone, which will be sterilized on their departure, but will be given computers and televisions.
The risk of succumbing to the virus will be explained to participants, as will the requirement to stay at the centre until medical staff authorize their discharge in the event that they develop symptoms. This is for their own safety and those of any people with whom they could come into contact. They will be advised to make contingency plans for a stay of seven days. The nearby university has a teaching hospital, and so there is ready access to emergency care in the unlikely event that it may be needed.
Participants will be screened for underlying health conditions that could affect their ability to cope with the norovirus. This will include pregnancy tests for women, and any pregnant women will be excluded. Also excluded will be those who care for someone for whom the norovirus poses a greater than normal health risk. Although it is acceptable for a person to consent to running the risk of contracting the virus themselves, it is not acceptable that this impose serious risks on others for whom they care.
Would you approve this trial?
Are there any additional safeguards you would recommend?